RISE UP RED EDITION Capsules — Class I drug recall D-0645-2022
Terminated recall by Positive Health, reported 2022-03-02, distributed nationwide. Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found
| Recall number | D-0645-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Positive Health, Wilmington, DE, United States |
| Recall initiated | 2022-02-10 |
| Classified | 2022-03-04 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2022-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 5,500 cartons |
| Reason classes | undeclared allergen, unapproved product |
| Lot numbers | 48658908 |
| Expiration dates | 2023-09-09 |
Product
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Reason for recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0645-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.